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Normec Yxion

Normec Yxion supports organisations in the pharmaceutical, biotech and medical devices industries with specialist expertise in the fields of Quality Assurance (QA), Commissioning, Qualification & Validation (CQV) and Process & Manufacturing Engineering (PME). With a team of experienced consultants, we help organisations achieve their quality and project objectives.

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About us

At Normec Yxion, it is about more than just the involvement of a single consultant. Our strength lies in the combined knowledge and experience of a full team of specialists. This enables us to offer our clients not only the right expertise, but also the flexibility and continuity required to successfully deliver projects.

We operate on the basis of shared responsibility for the project and tailor the deployment of our specialists to the organisation’s needs and the various project phases. Whether dealing with specialist issues within QA, CQV or PME, our consultants can draw on the knowledge and experience of their colleagues.

By combining specialist expertise with operational capacity, we ensure the efficient deployment of people and resources. This approach reduces reliance on any single consultant and allows us to respond flexibly to changing project requirements. In this way, we combine personal commitment with the knowledge, capacity and reliability of a full team.

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Services

Explore our services and discover how we can support you. With a wide range of solutions, we help you address a variety of challenges, tailored to your organization.

CQV Programme & Project Management

GxP Compliance and Auditing

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Commissioning, Qualification, and Validation (CQV)

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Interim Professionals

Staffing and training

Sectors

Explore our sectors and discover the markets in which we operate. With our expertise, we support organizations across a wide range of sectors with solutions tailored to their specific challenges.

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Pharma & Biotech industry

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Suppliers to the pharma industry

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Medical devices

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Hospitals

News

Normec is leading the way. Stay up to date.

15 Jul 2026

What if you took a completely different approach to Gowning? ​

When you think of gowning, you probably think of putting on protective clothing. The way employees dress in cleanrooms is key to preventing product contamination and ensures compliance with even the strictest standards related to Annex 1. A single small particle in the wrong place can make the difference between a perfect product and a lost batch.

15 Jul 2026

How to Become Fully Inspection-Ready According to Annex 1

What happens when inspectors enter your production environment? Do you really have everything in order? Or is there a risk that your processes will fall short at first glance? And how do you make your company inspection-proof? It starts with documentation. Unfortunately, a few neatly filed SOPs aren’t enough. Inspectors want more and are looking for evidence that your processes are robust and continuously monitored.

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15 Jul 2026

Innovative Approaches to Paperless Validation

Computerized System Validation (CSV) is the way to ensure the reliability, compliance, and data integrity of automated systems in regulated industries. With the shift toward digital transformation, paperless validation methods are gaining importance. This article explores innovative approaches and technologies that streamline the CSV process while maintaining compliance and data integrity.

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15 Jul 2026

Does your organization have complete control over all its processes?

Modern processes are monitored using sensors. These sensors indicate, for example, whether the product is being manufactured under the correct conditions. But can we always blindly trust the results these sensors record?

15 Jul 2026

What is risk assessment?

Risk management—that is, risk analysis and risk control—is important for every company. By conducting a risk analysis, you determine what the risks are, particularly those that threaten your business objectives. These include risks related to product quality and safety (such as (cross)contamination and mix-ups) and employee health and safety, as well as regulatory compliance. Corrective and/or preventive actions can then help reduce these risks and make them manageable. Discover the basic principles of risk management and learn how to identify, analyze, and mitigate potential risks.

15 Jul 2026

Gap Assessment Analysis

A gap analysis allows an organization to evaluate its current state of affairs in comparison to the desired situation or objectives. This method provides valuable insights for effectively achieving projects and business goals. During a gap analysis, for example, the maintenance process is critically examined. Essential questions are answered, such as: What are possible improvements to the process? How can we take asset maintenance to the next level? And how do we ensure safety in the maintenance process?

15 Jul 2026

What is the essence of an effective supply chain?

In the rapidly changing world of business operations, maintaining high-quality products during distribution is crucial. Our consultants have extensive knowledge of Good Distribution Practice (GDP) and its impact on efficient business operations. GDP goes beyond mere compliance with regulations. From temperature control to smart storage and seamless transportation, it is the essence of an effective supply chain.

Downloads & Links

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We are part of the Normec Group.

Normec is a leading organization in the TICC sector (Testing, Inspection, Certification, Compliance). Our areas of expertise range from (drinking) water quality, air quality, and soil quality to fire safety, food safety, management systems, fair labor practices, good working conditions, and social compliance. Every day, we work to create a safe, healthy, and reliable work and living environment—for this generation and those to come.